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Clinical Trial Details

Trial ID: L1820
Source ID: NCT06258148
Associated Drug: Tg103
Title: Phase 3 Study of TG103 Injection Monotherapy in Treatment of Type 2 Diabetes Mellitus
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: TG103|DRUG: Placebo
Outcome Measures: Primary: Changes in glycosylated hemoglobin (HbA1c) from baseline at 24 weeks of treatment, Baseline through Week24 | Secondary: Changes in HbA1c from baseline at 52 weeks of treatment, Baseline through Week52|The percentage of HbA1c≤6.5% and the percentage of HbA1c≤7% at week 24 and 52, Week24 and 52|Change in fasting plasma glucose (FPG) from baseline at week 24 and 52, Baseline through Week24 and 52|Change in weight from baseline at week 24 and 52, Baseline through Week24 and 52|Change in 2h-postprandial plasma glucose (2h-PPG) from baseline at week 24 and 52, Baseline through Week24 and 52|Change in mean 7-point blood glucose curve from baseline at week 24 and 52. Change in mean postprandial blood glucose increment from baseline at week 24 and 52., Baseline through Week24 and 52|Change in blood lipids (triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) from baseline at week 24 and 52, Baseline through Week24 and 52|Proportion of subjects receiving remedial therapy at week 24 and 52, Week24 and 52|Incidence of adverse events, Week-2 through 52|Blood concentrations of TG103, Week 0, 4, 8,16, 24,36, 44,52 and 55|The occurrence of TG103 anti-drug antibodies (ADA) and neutralizing antibody (NAb), Week 0, 4, 8,16, 24,36, 44,52 and 55
Sponsor/Collaborators: Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 300
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-03
Completion Date: 2026-11
Results First Posted:
Last Update Posted: 2024-02-14
Locations:
URL: https://clinicaltrials.gov/show/NCT06258148